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Form 8-K Design Therapeutics, For: Aug 08

August 8, 2022 4:09 PM EDT

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 08, 2022

 

 

Design Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-40288

82-3929248

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

6005 Hidden Valley Road

Suite 110

 

Carlsbad, California

 

92011

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (858) 293-4900

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.0001 par value per share

 

DSGN

 

NASDAQ Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 


 

Item 2.02

Results of Operations and Financial Condition.

 

On August 8, 2022, Design Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and six months ended June 30, 2022. A copy of the press release is attached hereto as Exhibit 99.1.

 

The information in this Item and the exhibit attached hereto are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, whether filed before or after the date hereof and regardless of any general incorporation language in such filing.

 

 

Item 9.01

Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release of Design Therapeutics, Inc. dated August 8, 2022

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

Design Therapeutics, Inc.

 

 

 

 

Date:

August 8, 2022

By:

/s/ João Siffert, M.D.

 

 

 

João Siffert, M.D.
President and Chief Executive Officer

 


Exhibit 99.1

img267412975_0.jpg 

 

 

Design Therapeutics Highlights Upcoming Milestones and Reports Second Quarter 2022 Financial Results

Initial Data from Friedreich Ataxia Phase 1 Trial of DT-216 Expected in the Fourth Quarter of 2022

Strong Financial Position with $359.4 Million in Cash and Securities to Support Multi-Year Operating Runway

 

Carlsbad, Calif., Aug. 8, 2022 – Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today highlighted anticipated upcoming milestones across its clinical and research-stage pipeline of novel GeneTACTM small molecules and reported second quarter 2022 financial results.

“Throughout the first half of 2022, we have successfully advanced our pipeline of novel GeneTAC™ small molecules designed to address the root cause of disease, without the need for irreversible gene therapy or gene editing. We believe this approach paves the way for disease-modifying treatments for many more patients with inherited genetic diseases,” said João Siffert, M.D., president and chief executive officer of Design Therapeutics. “Our Phase 1 clinical trial evaluating DT-216, our lead GeneTAC™ molecule, as a treatment for patients with Friedreich ataxia (FA) is progressing well and we look forward to sharing initial data in the fourth quarter of this year. In parallel, we’ve advanced our GeneTAC™ program for myotonic dystrophy type-1 (DM1), announced compelling preclinical data in Fuchs endothelial corneal dystrophy (FECD), and made meaningful strides across multiple earlier-stage research programs, all of which represent potentially transformative opportunities. With a financial runway to support our current multi-year operating plan, we continue to be well-positioned to execute our milestones.”

Upcoming Pipeline Milestones

Initial Data from Single-Ascending Dose Portion of Phase 1 trial for DT-216 Expected in the Fourth Quarter of 2022: DT-216, Design’s lead GeneTAC™ molecule, is designed to treat FA by specifically targeting the GAA repeat expansion mutation, the underlying cause of disease, and restore frataxin (FXN) gene expression. DT-216 is being evaluated in a Phase 1 clinical trial in adult patients with FA. The company plans to report initial data, including safety, tolerability, pharmacokinetics and FXN levels from the single-ascending dose portion of the trial in the fourth quarter of 2022. Design expects to initiate dosing of DT-216 in the multiple-ascending dose portion of the Phase 1 study, in the second half of 2022.
Clinical Development for DM1 Program Anticipated in 2023: Design’s GeneTACTM program for the treatment of DM1 is progressing through preclinical research. The company anticipates beginning clinical development in 2023.
Advancing Research in FECD Throughout the Second Half of 2022: The company is continuing to advance its preclinical research in FECD, a genetic eye disease characterized by progressive degeneration of the corneal endothelium and subsequent vision impairment. FECD affects millions of people worldwide and is the leading reason for tens of thousands of corneal transplants each year. When tested in vitro in FECD patient-derived corneal endothelial cells, Design’s FECD GeneTAC™ molecules led to nearly complete reductions in toxic nuclear RNA foci in a time- and

 


concentration-dependent manner. The data were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting in May 2022.

Second Quarter 2022 Financial Results

R&D Expenses: Research and development (R&D) expenses were $11.3 million for the quarter ended June 30, 2022.
G&A Expenses: General and administrative (G&A) expenses were $4.3 million for the quarter ended June 30, 2022.
Net Loss: Net loss was $15.0 million for the quarter ended June 30, 2022.
Cash Position: Cash, cash equivalents and marketable securities were $359.4 million as of June 30, 2022.

 

About Design Therapeutics

Design Therapeutics is a clinical-stage biotechnology company developing a new class of therapies based on its platform of GeneTAC™ gene targeted chimera small molecules. The company’s GeneTAC™ molecules are designed to either dial up or dial down the expression of a specific disease-causing gene to address the underlying cause of disease. Design’s lead program is focused on the treatment of Friedreich ataxia, followed by a program in myotonic dystrophy type-1 and discovery efforts for multiple other serious degenerative disorders caused by nucleotide repeat expansions. For more information, please visit designtx.com.

 

Forward-Looking Statements

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to projections from early-stage programs and preclinical data; potential transformative opportunities; expectations for reporting data and the timing thereof; Design’s ability to meet its stated milestones; the anticipated sufficiency of Design’s financial runway; the potential benefits of FXN restoration; the expected initiation of Design’s multiple-ascending dose Phase 1 clinical trial for DT-216 in patients with FA and the timing thereof; Design’s anticipated timeline to begin clinical development of its GeneTACTM program for the treatment of DM1 in 2023; Design’s FECD GeneTACTM program and its potential therapeutic benefits and advantages; Design’s belief that its approach paves the way for disease-modifying treatments for many more patients with inherited genetic diseases; Design’s ability to bring forward a new class of treatments for patients living with devastating genetic diseases; and the capabilities and potential advantages of Design’s pipeline of GeneTAC™ molecules. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “designed to,” “anticipates,” “planned,” “expects,” “estimate,” “intends,” “will,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Design’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with conducting a clinical trial and patient enrollment, which is affected by many factors, and any difficulties or delays encountered with such clinical trial or patient enrollment may delay or otherwise adversely affect Design’s ongoing Phase 1 clinical trial for DT-216; the process of discovering and developing therapies that are safe and effective for use as human therapeutics and operating as a development stage company; Design’s ability to develop, initiate or complete preclinical studies and clinical trials for its product candidates; the risk that promising early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials; changes in Design’s plans to develop its product candidates; uncertainties associated with performing clinical trials, regulatory filings and applications; risks associated with reliance on third parties to successfully conduct clinical trials and preclinical studies; Design’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory

 


developments in the United States and foreign countries; Design’s reliance on key third parties, including contract manufacturers and contract research organizations; Design’s ability to obtain and maintain intellectual property protection for its product candidates; Design’s ability to recruit and retain key scientific or management personnel; competition in the industry in which Design operates, which may result in others discovering, developing or commercializing competitive products before or more successfully than Design; and market conditions. For a more detailed discussion of these and other factors, please refer to Design’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of Design’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, as filed with the SEC on May 9, 2022, and under the “Risk Factors” heading of Design’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, being filed with the SEC on August 8, 2022. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Design undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

# # #

 

Contact:
Investors:

Chelcie Lister

THRUST Strategic Communications

[email protected]

 

 

 

 


DESIGN THERAPEUTICS, INC.

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

11,295

 

 

 

5,027

 

 

 

20,054

 

 

 

8,902

 

General and administrative

 

 

4,344

 

 

 

2,660

 

 

 

8,955

 

 

 

4,465

 

Total operating expenses

 

 

15,639

 

 

 

7,687

 

 

 

29,009

 

 

 

13,367

 

Loss from operations

 

 

(15,639

)

 

 

(7,687

)

 

 

(29,009

)

 

 

(13,367

)

Other income, net

 

 

640

 

 

 

51

 

 

 

745

 

 

 

217

 

Net loss

 

$

(14,999

)

 

$

(7,636

)

 

$

(28,264

)

 

$

(13,150

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.27

)

 

$

(0.14

)

 

$

(0.51

)

 

$

(0.36

)

Weighted-average shares of common stock outstanding, basic and diluted

 

 

55,670,780

 

 

 

55,081,397

 

 

 

55,589,510

 

 

 

36,459,244

 

 

 

 

 


DESIGN THERAPEUTICS, INC.

CONDENSED BALANCE SHEETS

(in thousands)

 

 

 

June 30,

 

 

December 31,

 

 

 

2022

 

 

2021

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash, cash equivalents and investment securities

 

$

359,377

 

 

$

384,064

 

Prepaid expense and other current assets

 

 

2,345

 

 

 

1,371

 

Total current assets

 

 

361,722

 

 

 

385,435

 

Property and equipment, net

 

 

1,804

 

 

 

1,508

 

Right-of-use asset, related party

 

 

3,932

 

 

 

3,614

 

Other assets

 

 

474

 

 

 

 

Total assets

 

$

367,932

 

 

$

390,557

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,071

 

 

$

1,620

 

Accrued expenses and other current liabilities

 

 

5,317

 

 

 

3,663

 

Total current liabilities

 

 

7,388

 

 

 

5,283

 

Operating lease liability, net, related party

 

 

3,381

 

 

 

3,144

 

Total liabilities

 

 

10,769

 

 

 

8,427

 

Convertible preferred stock

 

 

 

 

 

 

Total stockholders’ equity

 

 

357,163

 

 

 

382,130

 

Total liabilities and stockholders’ equity

 

$

367,932

 

 

$

390,557

 

 

 

 

 




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